BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS LASER

    MDR report key: 2824010 · Received December 17, 2010

    Report

    Report Number
    3006695864-2010-00146
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: EQUIPMENT WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AFTER THE EVENT. MECHANICAL AND PERFORMANCE TEST WERE PERFORMED INCLUDING A VISUAL EXAMINATION. FSE PERFORMED PREVENTIVE MAINTENANCE ON UNIT. NO PROBLEM WAS FOUND WITH EQUIPMENT. SYSTEM MEETS AMO SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT HAD A BILATERAL CUSTOM INTRALASE PROCEDURE ON (B)(6) 2010, WITHOUT COMPLICATION OR INCIDENT. AT 1 DAY POST OP, PATIENT HAD A QUESTIONABLE INFILTRATE AT SUPERIOR FRINGE OS VS EARLY DLK OS. ERRING ON SIDE OF CAUTION, SURGEON LIFTED FLAP AND IRRIGATED WITH VANCOMYCIN. PATIENT WAS RX'D ALTERNATING VANCOMYCIN AND ZYMAXID Q2HOURS OS AND INSTRUCTED TO NOT USE PRED FORTE OS. PATIENT RETURNED ON (B)(6) 2010 AT 10AM, WITH STAGE 1-2 DLK OU. PATIENT WAS PRESCRIBED PREDNISONE 40MD QD PO. ZYMAXID AND VANCOMYCIN WERE REDUCED TO TGTT QID OU. PATIENT RETURNED FOR FOLLOW UP ON (B)(6) 2010 AT 10AM, WITH NO PROGRESSION OR IMPROVEMENT. PATIENT WAS INSTRUCTED TO STAY ON CURRENT MEDICATION REGIMEN UNTIL RETURN VISIT. (B)(6) 2010 - PATIENT SEEN BY AFFILIATE AND DX WITH GRADE 3 DLK. FLAP LIFT AND IRRIGATED, KENOLOG. SEEN (B)(6) 2010, VASC 20/50 EACH EYE. NOTED CENTRAL HAZE AND SUB EPI MUD CRACK OU. CONT ON PF Q 1-2 HOURS, RE-CHECK 2 DAYS FOR POSSIBLE LIFT AND STRETCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE IFS LASER HNO AMO MANUFACTURING USA LLC 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other